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Claims for Patent: 8,466,139

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Claims for Patent: 8,466,139

Title:Formulation
Abstract: The invention relates to a novel sustained release pharmaceutical formulation adapted for administration by injection containing the compound 7.alpha.-[9-(4,4,5,5,5-pentafluoropentylsulphinyl)nonyl]oestra-1- ,3,5(10)-triene-3,17.beta.-diol, more particularly to a formulation adapted for administration by injection containing the compound 7.alpha.-[9-(4,4,5,5,5-pentafluoropentylsulphinyl)nonyl]oestra-1,3,5(10)-- triene-3,17.beta.-diol in solution in a ricinoleate vehicle which additionally comprises at least one alcohol and a non-aqueous ester solvent which is miscible in the ricinoleate vehicle.
Inventor(s): Evans; John R (Macclesfield, GB), Grundy; Rosalind U (Macclesfield, GB)
Assignee: AstraZeneca AB (SE)
Application Number:13/602,667
Patent Claims: 1. A method for treating a hormonal dependent benign or malignant disease of the breast or reproductive tract comprising administering intramuscularly to a human in need of such treatment a formulation comprising: about 50 mgml.sup.-1 of fulvestrant; a mixture of from 17-23% w/v of ethanol and benzyl alcohol; 12-18% w/v of benzyl benzoate; and a sufficient amount of castor oil vehicle; wherein the method achieves a blood plasma fulvestrant concentration of at least 2.5 ngml.sup.-1 for at least two weeks.

2. The method of claim 1, wherein formulation comprises a mixture of from 19-21% w/v of ethanol and benzyl alcohol and 14-16% w/v of benzyl benzoate.

3. The method of claim 1, wherein formulation comprises: about 10% w/v of ethanol; about 10% w/v of benzyl alcohol; and about 15% w/v of benzyl benzoate.

4. The method of claim 1, wherein the blood plasma fulvestrant concentration is at least 8.5 ngml.sup.-1.

5. The method of claim 1, wherein the hormonal dependent benign or malignant disease of the breast or reproductive tract is breast cancer.

6. The method of claim 1, wherein the blood plasma fulvestrant concentration is attained for at least four weeks.

7. The method of claim 1, wherein the method comprises administering intramuscularly to a human in need of such treatment 5 ml of the formulation.

8. The method of claim 1, wherein the method further comprises once monthly administration of the formulation.

9. The method according to claim 1, wherein the formulation is administered in a divided dose.

10. The method of claim 3, wherein the hormonal dependent benign or malignant disease of the breast or reproductive tract is breast cancer and the blood plasma fulvestrant concentration is attained for at least 4 weeks.

11. A method for treating a hormonal dependent benign or malignant disease of the breast or reproductive tract comprising administering intramuscularly to a human in need of such treatment a formulation consisting essentially of: about 50 mgml.sup.-1 of fulvestrant; a mixture of from 17-23% w/v of ethanol and benzyl alcohol; 12-18% w/v of benzyl benzoate; and a sufficient amount of castor oil vehicle; wherein the method achieves a blood plasma fulvestrant concentration of at least 2.5 ngml.sup.-1 for at least two weeks.

12. The method of claim 11, wherein formulation consists essentially of a mixture of from 19-21% w/v of ethanol and benzyl alcohol and 14-16% w/v of benzyl benzoate.

13. The method of claim 11, wherein formulation consists essentially of: about 10% w/v of ethanol; about 10% w/v of benzyl alcohol; and about 15% w/v of benzyl benzoate.

14. The method of claim 11, wherein the blood plasma fulvestrant concentration is at least 8.5 ngml.sup.-1.

15. The method of claim 11, wherein the hormonal dependent benign or malignant disease of the breast or reproductive tract is breast cancer.

16. The method of claim 11, wherein the blood plasma fulvestrant concentration is attained for at least four weeks.

17. The method of claim 11, wherein the method comprises administering intramuscularly to a human in need of such treatment 5 ml of the formulation.

18. The method of claim 11, wherein the method further comprises once monthly administration of the formulation.

19. The method according to claim 11, wherein the formulation is administered in a divided dose.

20. The method of claim 13, wherein the hormonal dependent benign or malignant disease of the breast or reproductive tract is breast cancer and the blood plasma fulvestrant concentration is attained for at least 4 weeks.
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